Regulatory Affairs

From ideation to commercialized product, our expert regulatory team is engaged in designing and executing the regulatory strategy and guiding the product development and product lifecycle. By working with the Food and Drug Administration, we can ensure a seamless and streamlined execution from initial application to efficient maintenance of the submission lifecycle beyond approval.

Through effective communication with the FDA, our regulatory department obtains alignment to our strategic regulatory pathway. Additionally, the team actively contributes and comments on new and upcoming regulations and policies with the agency.

We have a track record of more than 22 approved products (505(b)(2)s and ANDAs), several pending, and upcoming filings. Currently, there are five active INDs with the US Food & Drug Administration. We also have two products approved by Health Canada and 12 approved registrations in Europe.

In addition, we actively continue to monitor regulatory intelligence and regulatory compliance.

All of our submissions are electronic (eCTD). The regulatory department also manages safety, pharmacovigilance, DEA-research license, and compliance with Drug Marketing Advertising and Communication.